Food agency formed ‘erroneous conclusions too early,’ as supplement pulled over liver failure links
The supplement Hydroxycut Hardcore Next Gen, a MuscleTech brand owned by Iovate Health Sciences International, was flagged up by the Coordinated System for the Rapid Exchange of Information (SCIRI).
Health authorities at Madrid’s Pharmacovigilance Center suspected acute liver failure as the cause of death as authorities believed the product was bought via a Canadian-based website.
The actions prompted a swift response from Kelly Albert, Iovate’s chief operating officer, who revealed Spanish authorities informed them the patient in question was consuming other supplement products which may have contributed to the fatality.
“We are still in the process of verifying this information,” she said. “Given the lack of complete information from the initial news source surrounding this situation, combined with the potential influence of other ingestible products used simultaneously by the consumer, it is reasonable to assume there is high likelihood this report may have formed erroneous conclusions too early.”
“We look forward to collaborating fully with the Spanish authorities to determine the true cause behind the patient’s unfortunate fatality.
Further investigations by The Spanish Agency for Food Safety and Nutrition (AESAN) found the product to be marketed through numerous websites selling food supplements and products for athletes.
The product is also available on a number of sales platforms including on-line and stores specialising in food supplements.
“AESAN’s actions continue to prevent the ongoing commercialisation of this product through the internet,” the food alert said.
“It is recommended this product is NOT purchased and that if consumers have it at home, they refrain from consuming them.”
No prior notification
Albert added that Spanish authorities did not inform the company of their intentions to withdraw the product from Spanish markets.
AESAN’s assertions that the product was not registered in the country and thus could not be marketed there were refuted by Albert, who said the product was confirmed as notified and registered in Spain by a local distributor.
Albert also pointed out that Iovate had not been provided any details about the alleged incident from the Spanish authorities and had not reached out to the firm prior to issuing the food alert.
“Immediately after learning of the incident, Iovate reached out to the Spanish authorities to attempt to obtain details and are still awaiting a response after almost a week,” said Albert.
“We have not received any information that any of our products caused or contributed to the patient’s unfortunate condition.”
“If the Spanish authorities had reached out to us beforehand, they would have known we have sold nearly half a million bottles of this exact formula with absolutely zero reported cases alleging liver toxicity or fatality (with the exception of the unconfirmed event),” she added.
L-Ornithine Hydrochloride
Marketed as a weight loss aid, Hydroxycut Hardcore Next Gen’s comes in capsule form with the amino acid L-Ornithine Hydrochloride as its primary active ingredient.
Other ingredients include caffeine, green coffee bean extract (as Coffea canephora robusta), supplying 45% chlorogenic acids, green tea extract (as Camellia sinensis) (leaf), blue skullcap extract (as Scutellaria lateriflora) (root), red sage extract (as Salvia miltiorrhiza) (root) and ginger (as zingiber offcinale) (root).
“Every single unit from every production lot of Hydroxycut products are supported by human clinical research for both safety and efficacy,” Albert pointed out.
“Iovate is absolutely committed to the safety of its products and would not knowingly sell any product that is harmful.”
“Based on the information received to date and Iovate’s ongoing investigation, Iovate believes the Product does not pose safety risks to consumers.”
AESAN is to communicate these details through the SCIRI to the relevant authorities including the Spanish Agency for Medicines and Health Products (AEMPS) and to the Coordination Center for Alerts and Health Emergencies (CCAES),
In addition, the Services of the European Commission through the European Food Alert Network (RASFF), has been notified, who have verified the withdrawal of the product from all marketing channels.
RASFF’s notification indicates authorities in France, Netherlands, Poland, Portugal and Slovakia amongst other countries have been notified.
